NG101m Adjuvant Therapy in Glioblastoma Patients

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical trial is to evaluate the addition of NG101m adjuvant therapy to standard of care treatment of glioblastoma multiforme. All subjects will receive NG101m capsules along with the standard treatment of temozolomide and radiation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeuGATE Theranostics
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

• Male or female subjects ≥ 18 years of age

• Must be newly diagnosed with GBM

• Primary treatment must consist of a chemoradiation therapy (CRT) regimen

• Hemoglobin > 9 g/dL

• White blood count 3,600 - 11,000/mm3

• Absolute neutrophil count (ANC) ≥ 1,500/mm3

• Absolute lymphocyte count (ALC) ≥ 1,000/mm3

• Platelet count 100,000/mm3

• BUN ≤ 1.5 times upper limit of normal

• Creatinine clearance rate > 40 mL/min

• ALT ≤ 3 times upper limit of normal

• AST ≤ 3 times upper limit of normal

• Alkaline phosphatase ≤ 3 times upper limit of normal

• Total bilirubin ≤ 2.0 mg/dL

• Karnofsky Performance Status ≥ 70

• Must not be on any other alternative therapies

• Not pregnant

Exclusion Criteria:

• Known hypersensitivity to meloxicam, famotidine, and/or caffeine or any of their derivatives or components

• Known allergy to vitamin A, vitamin D3, and/or L-citrulline

• Pregnant women

• Breastfeeding women

• Corticosteroid therapy that cannot be tapered down to a dose of 1 - 2 mg/day of dexamethasone or its equivalent

• History of immunodeficiency diseases or autoimmune diseases

• History of peptic ulcer disease or gastrointestinal perforation